ISO 13485 Quality Management Systems for Medical Device Manufacturers with FDA QMSR (USA/Canada) — 2026 Update
Now updated with FDA QMSR, Canada MDSAP, full lifecycle traceability, and advanced validation techniques.
This course is certified by Exemplar Global.
This intensive 1‑day training provides medical device manufacturers and suppliers with the essential knowledge required to implement, maintain, or upgrade a fully compliant Quality Management System (QMS) according to ISO 13485:2016.
You will learn how to interpret and operationalize the standard’s process‑oriented, regulatory‑driven requirements and understand how ISO 13485 integrates with global regulations such as EU MDR/IVDR, U.S. FDA QMSR (effective Feb 2, 2026), and Canada’s CMDR/MDSAP.
The training addresses critical implementation topics now central to regulatory compliance, including risk‑based QMS controls, design & development traceability, supplier and outsourced process control, software validation, process validation, post‑market surveillance (PMS), and the transition from FDA’s DMR/DHF/DHR terminology to the Medical Device File (MDF).
By participating in this training course, you will be able to:
- Understand ISO 13485:2016: Gain knowledge of the process-oriented standard for management systems in the medical device industry.
- Implement ISO 13485:2016: Ensure meaningful implementation of the standard in your company.
- Optimize Processes: Improve your processes during the introduction of a management system.
- Stay Updated: Get an overview of the current state of standardization and international regulatory requirements.
- Learn Documentation Requirements: Understand the documentation requirements and differences from ISO 9001:2015.
Join us for this essential 1-day training course to enhance your understanding of ISO 13485:2016 and ensure your organization meets the highest standards of quality and safety. Enroll today and take the first step towards implementing a robust management system for medical devices!
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is ideal for experts and executive personnel of medical device manufacturers and their suppliers that are involved in quality management system introduction, establishment and maintenance in the area of medical devices. And for all professionals in the manufacturing and supply of medical devices who want to gain a basic understanding of management systems and regulatory requirements, including:
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Compliance Officers
- Design & Development Engineers
- Production & Operation Managers
- Supplier Quality Engineers
- Medical Device Manufacturers & Contract Manufacturers
Course Topics at a Glance
1. Foundations of ISO 13485:2016
- Structure, purpose, and regulatory alignment
- Process approach and risk‑based thinking
- Mandatory documentation & records; the Medical Device File (MDF)
2. ISO 13485 and Global Regulations
- MDR/IVDR Annex Z mapping
- FDA QMSR: ISO 13485 alignment & remaining U.S.-specific requirements
- CMDR & MDSAP expectations for Canadian market access
- QMS roles under MDR/IVDR and international frameworks
3. Product Lifecycle Controls
- Design & development (V‑Model, waterfall model, design transfer)
- Verification, validation, usability, clinical/performance evaluation
- Production controls, cleanliness, installation, servicing
4. Validation Requirements
- Process validation (IQ, OQ, PQ)
- Software validation for QMS tools, production systems, and monitoring software
- Test method validation, equipment qualification
5. Change Management
- Engineering change control
- Product & QMS changes
- Regulatory reporting thresholds
- Impact analysis across design, production, software, risk, suppliers
6. Post‑Market Surveillance
- Feedback, complaints, vigilance, reporting to authorities
- Data analysis & CAPA
- PMS as an input to risk management and design changes
Enhance Quality and Safety with Our 1-Day Training on ISO 13485 for Medical Device Manufacturers.
Boost your company's quality and safety by mastering the implementation of management systems in the medical device industry. Our 1-day training course on Management Systems for Medical Device Manufacturers according to ISO 13485 is designed to help you effectively transfer the requirements of applicable standards to your organization.
One of the key challenges in introducing an effective management system is understanding and applying the requirements of ISO 13485:2016, which has a process-oriented structure. This seminar will guide you through the standard's requirements and help you implement them sensibly in your company. You will learn what to look out for when introducing or adapting the management system and understand the success factors, and you will acquire the necessary knowledge to install a management system as a manufacturer of medical devices or as a supplier in the medical device industry. The training will cover special focal points of ISO 13485:2016, including:
- Risk Management
- Change Management
- Software Validation
- Extended Requirements for Development and Market Monitoring
These aspects are becoming increasingly important!
By the end of the training, participants will be able to:
- Master ISO 13485:2016 Requirements
- Understand the structure, clauses, and intent of ISO 13485:2016 and how to apply them effectively in your organization.
- Identify key differences between ISO 13485 and ISO 9001:2015 (documentation, risk, regulatory orientation, process controls).
- Implement a Regulatory-Compliant QMS
- Integrate applicable regulatory requirements into the QMS, including MDR/IVDR, QMSR, CMDR/MDSAP.
- Understand organizational regulatory roles (manufacturer, AR, importer, distributor) and expectations under global frameworks.
- Strengthen Risk‑Based Processes
- Apply risk‑based thinking to QMS processes (clauses 4–8).
- Understand the relationship between ISO 13485, ISO 14971, and regulatory expectations.
- Control the Full Product Lifecycle
- Understand design and development planning, inputs, outputs, reviews, verification & validation (V&V), and change control requirements.
- Implement bidirectional design traceability from inputs → outputs → V&V → risk controls.
- Manage production controls, cleanliness, contamination control, identification & traceability, UDI, and servicing.
- Apply Validation Requirements
- Learn when to use IQ/OQ/PQ for process validation.
- Validate QMS software, production software, and measurement software according to ISO/TR 80002‑2 & GAMP5 principles.
- Ensure Market Safety Through PMS
- Implement complaint handling, vigilance reporting, trend analysis, and PMS systems aligned with regulatory expectations (8.2.1–8.2.3).
This course is taught by TÜV SÜD’s industry experts and is certified by Exemplar Global.
Join us for this essential 1-day training course to enhance your understanding of ISO 13485:2016 and ensure your organization meets the highest standards of quality and safety. Enroll today and take the first step towards implementing a robust management system for medical devices!
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation today
This training addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognized TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
What’s New in This Version of the Course?
Major Updates Reflecting Global Regulatory Changes and Expanded Expert Content
This latest release of the ISO 13485:2016 Quality Management Systems for Medical Device Manufacturers training has been significantly enhanced to reflect the most up‑to‑date regulatory expectations, evolving global requirements, and deeper practical guidance for implementation.
Here’s what’s new:
1. U.S. FDA QMSR Integration (Effective Feb 2, 2026)
A major addition: full coverage of the Quality Management System Regulation (QMSR) replacing the legacy QSR.
New content now explains:
- How QMSR formally incorporates ISO 13485:2016 and ISO 9000:2015 Clause 3 terms.
- Which FDA‑specific requirements remain: UDI (830), MDR reporting (803), Corrections & Removals (806), Device Tracking (821).
- Transition from DMR/DHF/DHR to the Medical Device File (MDF) structure.
- FDA’s updated inspection posture, including access to management review, internal audits, and supplier audits.
2. Expanded Canada Content: CMDR & MDSAP
Completely new Canada‑focused training elements:
- Licensing structure (MDEL vs MDL) and MDSAP requirements.
- Bilingual labeling requirements (EN/FR).
- Summary Reports, incident reporting, recall expectations.
- How to audit to ISO 13485 + CMDR + MDSAP simultaneously.
3. Deep Dive into Design & Development Controls
A substantial expansion of Clause 7.3 content:
- Full explanation of the V‑Model and waterfall model for medical devices.
Detailed examples for:- Design inputs
- Outputs
- Verification & validation
- Traceability matrices
- Design transfer
- Change control and regulatory implications
- New visuals, diagrams, and lifecycle mapping.
4. Enhanced Traceability & Identification Requirements
You now have a richer, more detailed module on:
- Bidirectional traceability (inputs → outputs → V&V → risk controls).
- Production traceability (lot, batch, serial number).
- UDI integration under both EU MDR and U.S. FDA QMSR.
- Traceability examples across design, manufacturing, and PMS.
5. Expanded Process Validation Section (IQ/OQ/PQ & More)
A significantly upgraded section now includes:
- Detailed definitions of IQ, OQ, PQ.
- Examples of processes requiring validation (sterilization, bonding, welding, CNC, packaging, etc.).
- Statistical techniques & sample justification.
- Validation master planning.
- Revalidation triggers and change impact analysis.
6. Comprehensive Software Validation Content (CSV / CSA)
Newly added content fully breaks down:
- ISO/TR 80002‑2:2017
- GAMP 5 categories
- FDA Draft CSA approach (2022)
- Validation requirements for:
- QMS software
- Production & process software
- Monitoring/measurement software
- Spreadsheets, macros, automated test systems
- Real‑world examples.
7. Stronger Emphasis on Risk‑Based QMS Implementation
The new version now distinguishes between:
- Product risk management (ISO 14971)
- Risk‑based QMS control (clauses 4–8)
- How risk ties into design, suppliers, validation, PMS, and changes.
- Tools: SWOT, What‑If, trending, risk matrices.
8. Expanded PMS, Complaint Handling & Vigilance Content
A much more detailed overview of PMS processes:
- Complaint handling workflows and examples.
- Reporting to authorities (EU, FDA, Health Canada).
- Summary reports, CAPA linkage, PMS plan structure.
- How PMS feeds risk management and design changes.
- Multiple example complaint forms included.
9. Supplier & Outsourced Process Controls Expanded
New coverage includes:
- MDR Article 10(9)(d) and NB Recommendation 2013/473/EU.
- Quality agreements, supplier classification, critical subcontractors.
- Risk‑based supplier control and re‑evaluation.
- Outsourced process visibility in the QMS.
10. New Implementation Focus Modules
Five high‑impact implementation topics now covered with practical guidance:
- Change Management
- Product Development
- Process Validation
- Software Validation
- Market Feedback / PMS
Each is expanded with workflows, diagrams, and regulatory expectations.
This Version = Deeper, More Practical, More Global
This updated course now:
- Reflects the global regulatory landscape of 2026.
- Includes modern tools and methodologies.
- Provides more implementation guidance and real‑world examples.
- Offers significantly expanded technical depth while keeping the format suitable for a 1‑day course.